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NCT02015065 · ClinicalTrials.gov registry record · Phase 2
Phase II Trial of Vandetanib in Children and Adults With Wild-Type Gastrointestinal Stromal Tumors
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 9
- Enrollment target
NCT02015065: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT02015065 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 9 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02015065, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 9 participants
- Enrollment target
Study Summary
Background: -Some people with wild-type gastrointestinal stromal tumors (WT-GIST) have a deficiency in one of their proteins called succinate dehydrogenase (SDH). Vandetanib is a cancer drug that has been approved to treat thyroid cancer and has been used with some success in other tumors that have a similar loss of SDH. Researchers want to see if this drug can also decrease tumor growth in people with WT-GIST. Objectives: -To test whether the study drug will benefit people with WT-GIST. Eligibility: -Adults and children 3 years old and older with WT-GIST. Design: * Researchers will test participants tumor tissue to confirm it is the wild type of GIST. * Participants will be screened with a medical history, physical exam, and blood tests. They will also have electrical recording of the heart (Eastern Cooperative Oncology Group (ECOG)) and scans of the tumor. * Participants will take the study drug in 28-day cycles. Their doctor will decide how many cycles they can complete. * They will take the study drug once every day and record it in a diary. * On Day 14, they will also visit their doctor to look for side effects. * Before cycles 2, 3 and 4, participants will have a physical exam, urine tests, blood pressure check, and blood tests. These tests will then be done periodically for as long as they are in the study. * Before cycle 4, scans will be done to check the size of the cancer. Most of these will be repeated every 3-6 cycles. * When they stop taking the study drug, participants will return to the clinic for a physical exam and blood tests.
Interventions
- DRUG Vandetanib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2013-12-14 |
| Est. Completion | 2019-12-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02015065
The ClinicalTrials.gov registry entry for NCT02015065 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Vandetanib is the first listed.
NCT02015065 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02015065 about?
NCT02015065 is a clinical study titled "Phase II Trial of Vandetanib in Children and Adults With Wild-Type Gastrointestinal Stromal Tumors". Background: -Some people with wild-type gastrointestinal stromal tumors (WT-GIST) have a deficiency in one of their proteins called succinate dehydrogenase (SDH). Vandetanib is a cancer drug that has been approved to treat thyroid cancer and has been used with some success in other tumors that have...
What is the current status of trial NCT02015065?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2013-12-14. Estimated completion is 2019-12-10.
What interventions are being tested in trial NCT02015065?
The interventions under investigation include: Vandetanib (DRUG).
Who is sponsoring clinical trial NCT02015065?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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